Baxter Healthcare Corporation Recall 87739
Description: Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Baxter Healthcare Corporation Recall 87739 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1684-2021 |
Event ID | 87739 |
Event Description | Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. |
Product Type | Devices |
Distribution | Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway. |
Quantity | 17,487 units |
Recall Reason | There is a potential leak between the venous patient connector and patient's hemodialysis access. |
Device Classification | 20210602 |
Device Code Info | Product Code: 101025; Lot 1000276191, UDI: 37332414007837 |
Center Classification Date | 20210526 |
Recall Initiation Date | 20210414 |
Recalling Firm | Baxter Healthcare Corporation |
Initial Notification | Letter |
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